510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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NRZClass III

Ablation System, High Intensity Focused Ultrasound (Hifu), Mr-Guided

Unknown
FDA source (opens on fda.gov)

NRZ is the FDA product code for Ablation System, High Intensity Focused Ultrasound (Hifu), Mr-Guided, a class III device type. FDA's definition for this code reads: "An MR-guided focused ultrasound system is intended to use HIFU to ablate soft tissue. MR imaging and thermal mapping are used to plan and monitor the use of ultrasound ablation before and during the procedure". As of , FDA records hold no 510(k) clearances under this code and no recalls.

Classification record

Product code
NRZ
Device name
Ablation System, High Intensity Focused Ultrasound (Hifu), Mr-Guided
FDA definition
An MR-guided focused ultrasound system is intended to use HIFU to ablate soft tissue. MR imaging and thermal mapping are used to plan and monitor the use of ultrasound ablation before and during the procedure.
Device class
Class III
Review panel
Unknown
Submission type
PMA
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
0
Ingested recalls
0

Companies listing this code with FDA

Companies whose registered establishments list this code